NCT03311672 - T-Cell PET Imaging With [18F]F-AraG in Lung Cancer | Crick

Overview

This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single \[18F\]F-AraG PET exam as part of this study. \[18F\]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of \[18F\]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.

This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single \[18F\]F-AraG PET exam as part of this study. \[18F\]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of \[18F\]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses. A total of 20 patients will be enrolled over an accrual period of approximately 12 months. Approximately 10 patients will be enrolled in the immunotherapy alone cohort and approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation therapy cohort. Patients will be evaluated one day and one week via telephone after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Non-small Cell Lung Cancer

Interventions

[18F]F-Ara-GDRUG

Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.

PembrolizumabDRUG

All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.

PET/CT scanRADIATION

Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Histologically or cytologically documented stage I-IIIA non-small cell lung cancer (NSCLC) 3. Eligible for with plan to undergo immunotherapy alone or both immunotherapy and stereotactic radiation therapy as part of NCT03217071 4. In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study 5. Able to provide informed consent and follow the study guidelines Exclusion Criteria: 1\. Female patients who are pregnant or breastfeeding

Outcomes

Primary Outcomes

The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by [18F]F-AraG PET (SUVmax)

The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by \[18F\]F-AraG PET (SUVmax)

Time frame: Baseline (after two cycles of pembrolizumab)

Secondary Outcomes

The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET

The detection of out-of-target radiation-mediated immune modulation in lymph nodes using \[18F\]F-AraG PET

Time frame: Baseline (after two cycles of pembrolizumab)